Testing a device that checks the edges of the removed breast tumour during surgery to help avoid a second operation

Single-arm feasibility study using MarginProbe® radiofrequency spectroscopy device during breast-conserving surgery. The device assesses all six surfaces of the excised tumour specimen for cancer cells; if positive, surgeon performs directed cavity shaves before closure. Device description and application: MarginProbe® is a radiofrequency spectroscopy system used intraoperatively to assess margins of the excised breast tissue during breast-conserving surgery. After the specimen is removed, the sterile probe is applied to all six surfaces of the specimen (lateral, medial, superior, inferior, anterior, deep) in the sterile field to detect residual cancer. Positive readings prompt directed cavity shaves. Duration of application: Approximately 5–10 minutes added to standard operative time. Training for surgeons/medical staff: All participating breast surgeons will complete device training before study initiation. Training will be provided by the research team of the supplier (Dilon Technologies Inc.) during the pre-study onboarding phase (prior to first intervention) and documented in a training log. Strategies to assess adherence: Adherence will be monitored through operative notes, case report forms, and review of hospital medical records. Device use per protocol and operative details will be recorded immediately post-surgery.